Post-operative Infections
Conditions
Keywords
IV contamination, intravenous contamination, stopcock contamination, surgical site infection
Brief summary
The purpose of this study is to investigate whether implementing a novel syringe and IV stopcock cap system impregnated with alcohol will reduce IV catheter bacterial contamination and infections in patients.
Detailed description
Bacterial contamination of patient intravenous stopcock sets is a common intraoperative event associated with increased patient mortality, possibly via an infectious mechanism. The most common type of intravenous tubing used in operating rooms is the open lumen stopcock set which lacks a barrier between the environment and intraluminal space, and thus the intravascular space of the patient. The stopcock connector can be easily contaminated by provider hands due to improper handling of the device and/or contaminated by soiled syringe tips subsequently connected to the device. Further, the stopcock connector is often left uncapped by the provider and directly exposed to the environment. Thus, common breaches in intraoperative aseptic practice of healthcare providers can lead to bacterial contamination of the endoluminal space of the open lumen device. The primary aim of the current study is to assess the efficacy of a passive bundle designed to decrease intravenous stopcock and tubing intraluminal bacterial contamination. This passive bundle includes two novel interventions, a DOCit station and HubScrub caps. The HubScrub is designed to clean the needleless connectors and open lumen stopcock systems. The DOCit station is designed to simultaneously clean the interior and exterior of needle-less luer connectors of syringes with isopropyl alcohol while also providing a method of storage and organization of multiple syringes. The investigators hypothesize that the application of this passive bundle to the standard open lumen system commonly employed by anesthesia providers in the operating room will significantly reduce bacterial contamination of standard 3-way open lumen stopcock sets and improve patient safety.
Interventions
DEVICEPassive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt
Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.
Sponsors
PSI Medical
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patient undergoing surgery or procedure in operating room * Undergoing general anesthesia
Exclusion criteria
* Children (age \< 18 years) * Lack of intravenous access * failure of anesthesia provider to complete training on experimental device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Bacterial IV Stopcock Lumen Contamination | 48 hours | The presence of bacteria in the stopcock lumen was assessed by analyzing swab cultures of the lumens. Each swab potentially containing bacteria from any of the 3 lumens of the stopcock sets were analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination | Until positive, up to 5 days | Open lumen ports were removed from the patient; sent directly to the anesthesiology microbiology laboratory; connected by the same clinical laboratory scientist to sterile catheters using sterile, aseptic technique; and injected directly into a BacT/Alert 3D system (bioMérieux Inc., Durham, NC) with 2 mL of sterile saline per port. BacT/Alert is a blood culture system that automatically monitors bacterial growth using colorimetry; a sensor inserted at the bottom of the bottle changes color on detecting the carbon dioxide produced by the growth of the bacteria. Catheters were then removed, and the bottles were directly incubated in the BacT/Alert system for 5 days or until positive. Once positive, the liquid in the bottle was examined to identify the organism. |
Countries
United States
Participant flow
Recruitment details
The study was conducted over 3-month period (Aug 1, 2011 to Nov 8, 2011) at Dartmouth-Hitchcock Medical Center, a tertiary care and level 1 trauma center in New Hampshire with 400 inpatient beds and 28 operating suites. The operating rooms enrolled during the study period were randomly selected on a daily basis from the available 28 operating rooms
Participants by arm
| Arm | Count |
|---|---|
| Control Control arm using standard of care operating room procedures and equipment | 306 |
| Experimental Group Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment. | 266 |
| Total | 572 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | lost sample | 8 | 14 |
Baseline characteristics
| Characteristic | Control | Experimental Group | Total |
|---|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 16.3 | 57.5 years STANDARD_DEVIATION 15.7 | 57.6 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 306 participants | 266 participants | 572 participants |
| Sex: Female, Male Female | 162 Participants | 142 Participants | 304 Participants |
| Sex: Female, Male Male | 144 Participants | 124 Participants | 268 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 572 |
| other Total, other adverse events | 86 / 572 |
| serious Total, serious adverse events | 0 / 572 |
Outcome results
Primary
Presence of Bacterial IV Stopcock Lumen Contamination
The presence of bacteria in the stopcock lumen was assessed by analyzing swab cultures of the lumens. Each swab potentially containing bacteria from any of the 3 lumens of the stopcock sets were analyzed
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Presence of Bacterial IV Stopcock Lumen Contamination | 41 percent stopcock contamination rate |
| PSI Experimental | Presence of Bacterial IV Stopcock Lumen Contamination | 32 percent stopcock contamination rate |
95% CI: [0.63, 0.98]
Secondary
Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination
Open lumen ports were removed from the patient; sent directly to the anesthesiology microbiology laboratory; connected by the same clinical laboratory scientist to sterile catheters using sterile, aseptic technique; and injected directly into a BacT/Alert 3D system (bioMérieux Inc., Durham, NC) with 2 mL of sterile saline per port. BacT/Alert is a blood culture system that automatically monitors bacterial growth using colorimetry; a sensor inserted at the bottom of the bottle changes color on detecting the carbon dioxide produced by the growth of the bacteria. Catheters were then removed, and the bottles were directly incubated in the BacT/Alert system for 5 days or until positive. Once positive, the liquid in the bottle was examined to identify the organism.
Time frame: Until positive, up to 5 days
Population: Specific data for each arm can not be obtained. Sincere efforts were made to obtain and report the data, however, no data is available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination | 86 cases of effluent contamination |
95% CI: [0.62, 1.35]